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The Tailored-H Cervical Stand-Alone anterior cervical interbody fusion system indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one or two contiguous disc levels. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radios. The Tailored-H Cervical Stand-Alone System is used to facilitate intervertebral body fusion in the cervical spine and is placed via an anterior approach at one- or two-disc levels (C2-T1) using autograft bone. Patients should have at least six (6) weeks of nonoperative treatment. The Tailored-H Cervical Stand-Alone Interbody Fusion System is intended to be used with the bone screw fixation provided and requires no additional fixation.

The Tailored-H Cervical Stand-Alone System is an internal spinal fixation system consisting of additively manufactured interbody devices and machined titanium bone screws. It is designed to provide mechanical support to the cervical spine while arthrodesis occurs. The Tailored-H Cervical Stand-Alone System is available in a variety of lordosis and footprint options with a porous architecture to offer increased capacity for bone growth and mechanical properties to suit the individual pathology and anatomical conditions of the patient. The Tailored-H cages are additively manufactured from titanium alloy Ti-6Al-4V ELI per ASTM F3001. The fixation screws and face plates are machined from titanium alloy Ti-6Al-4V ELI per ASTM F136 and ISO 5832-3.